81.3% Cardiovascular outcomes trials (CVOTs) are a robust method to evaluate the safety of drugs, focusing on cardiovascular (CV) outcomes. CVOTs were advised by the US Food and Drug Administration (FDA) in 2008 for all new type 2 diabetes (T2D) treatments. 1 In the LEADER trial, Victoza ® met the primary objective of showing non-inferiority (no increased CV risk) vs placebo, both on top of standard of care, as well as demonstrating superiority with a statistically significant reduction in cardiovascular risk. 2 LEADER was a randomised, double-blind, placebo-controlled CVOT, undertaken to assess the long-term effects of liraglutide on CV outcomes and other clinically important events in adults with T2D and high CV risk. 3 Selected secondary endpoints 3 • First occurrence of an expanded composite CV outcome of CV death, non-fatal MI, non-fatal stroke, revascularisation, hospitalisation for unstable angina or hospitalisation for heart failure • Serious adverse events and medical events of special interest • Time from randomisation to all-cause death • Time from randomisation to each individual component of the expanded composite CV outcome • Time from randomisation to individual and composite microvascular outcomes (eye and kidney) Primary endpoint 3 • The time from randomisation to a composite outcome of the first occurrence of CV death, non-fatal myocardial infarction (MI), or non-fatal stroke. These endpoint definitions follow FDA guidance for major adverse cardiovascular events (MACE) 1. FDA. Guidance for industry diabetes mellitus– evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes. 2008. Available at: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm071627.pdf Last accessed: February 2016. 2. Novo Nordisk. Company announcement 4 March 2016. Victoza ® significantly reduces the risk of major adverse cardiovascular events in the LEADER trial. Available at: https://www.novonordisk.com/bin/getPDF.1991879.pdf Last accessed: May 2016. 3. Marso SP, Poulter NR, Nissen SE, et al. Design of the liraglutide effect and action in diabetes: evaluation of cardiovascular outcome results (LEADER) trial. American Heart Journal. 2013; 166:823–830. 9,340 patients 410 trial sites 32 countries Followed for 3.5 – 5 years Prior cardiovascular disease (CVD) High CV risk without prior CVD 64.3% men 35.7% women USA 2,514 patients Brazil 939 patients UK 453 patients Germany 448 patients India 401 patients Countries with the highest trial participation 3 HQMMA/VT/0316/0149 Date of approval: May 2016 Internal Use Only Mean HbA 1c 8.7 ± 1.5% Mean BMI 32.5 ± 6.3 kg/m 2 Mean age 64.3 ± 7.2 years

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Page 1: LEA-003-41 Victoza Leader Infographic fa1b › ... › Victoza_Leader_Infographic_upda…High CV risk without prior CVD 64.3% men 35.7% women USA 2,514 patients Brazil 939 patients

81.3%

Cardiovascular outcomes trials (CVOTs) are a robust method to evaluate the safety of drugs, focusing on cardiovascular (CV) outcomes. CVOTs were advised by the US Food and Drug Administration (FDA) in 2008 for all new type 2 diabetes (T2D) treatments.1 In the LEADER trial, Victoza® met the primary objective of showing non-inferiority (no increased CV risk) vs placebo, both on top of standard of care, as well as demonstrating superiority with a statistically signi�cant reduction in cardiovascular risk.2

LEADER was a randomised, double-blind, placebo-controlled CVOT, undertaken to assess the long-term effects of liraglutide on CV outcomes and other clinically important events in adults with T2D and high CV risk.3

Selected secondary endpoints3

• First occurrence of an expanded composite CV outcome of CV death, non-fatal MI, non-fatal stroke, revascularisation, hospitalisation for unstable angina or hospitalisation for heart failure

• Serious adverse events and medical events of special interest

• Time from randomisation to all-cause death

• Time from randomisation to each individual component of the expanded composite CV outcome

• Time from randomisation to individual and composite microvascular outcomes (eye and kidney)

Primary endpoint3 • The time from randomisation to a composite outcome of the �rst occurrence of CV death, non-fatal myocardial infarction (MI), or non-fatal stroke. These endpoint de�nitions follow FDA guidance for major adverse cardiovascular events (MACE)

1. FDA. Guidance for industry diabetes mellitus– evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes. 2008. Available at: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm071627.pdf Last accessed: February 2016.

2. Novo Nordisk. Company announcement 4 March 2016. Victoza® signi�cantly reduces the risk of major adverse cardiovascular events in the LEADER trial. Available at: https://www.novonordisk.com/bin/getPDF.1991879.pdf Last accessed: May 2016.

3. Marso SP, Poulter NR, Nissen SE, et al. Design of the liraglutide effect and action in diabetes: evaluation of cardiovascular outcome results (LEADER) trial. American Heart Journal. 2013; 166:823–830.

9,340patients

410trial sites

32countries

Followed for

3.5 – 5 years

Prior cardiovasculardisease (CVD)

High CV risk withoutprior CVD 64.3%

men35.7%women

USA2,514 patients

Brazil939 patients

UK453 patients

Germany448 patients